DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Exposure
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall (Fresenius product category) with no reported illnesses, injuries, or deaths. The hazard is temperature exposure with unknown clinical impact, and no harm has been reported. Class III recalls are typically scored 1 or 2 per the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose (Low magnesium, Low Calcium) in two package sizes: 2500 mL (NDC 49230-209-94) and 2000 mL packs of 5 (NDC 49230-209-92). A total of 39 cases have been recalled nationwide.
The recall was initiated because the product was exposed to temperatures outside the specified limits. The affected lot numbers are 20PU02010 (2500 mL, expiration June 2022) and 20SU04033 (2000 mL, expiration July 2022).
DELFLEX is a prescription dialysis solution administered intraperitoneally for patients requiring peritoneal dialysis. Healthcare providers and patients who have this product should discontinue use and contact Fresenius Medical Care for guidance on replacement product.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- temperature-abuse
- storage-condition-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) 20PU02010
- Exp. date June 2022 and b) 20SU04033
- Exp. date July 2022
Distribution
Distributed nationwide across the United States.
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